![PANAMA JACK BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) SPRAY [PRIME PACKAGING, INC.]](https://medic.hrt.org//dailymed/images/81691e42-780f-a6de-e053-2a91aa0ac935/13630-0137-4.jpg)
| NDC | 13630-0137-4 |
| Set ID | 81691e42-780f-a6de-e053-2a91aa0ac935 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Prime Packaging, Inc. |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- Active Ingredients
- Purpose
- Uses
-
Warnings
For external use only
When using this product keep out of eyes. Rinse with water to remove. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120 0F
-
Directions
- Spray liberally and spread evenly by hand 15 minutes before sun exposure
- Hold container 4 to 6 inches from the skin to apply
- Do no spray directly into face. Spray on hands then apply to face
- Do not apply in windy conditions
- Use in well-ventilated areas
- Reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
-
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: Ask a doctor
- Inactive ingredients
- Other information
- Questions or comments?:
- Panama Jack 30 Broad Spectrum SPF 30 Sunscreen Spray
-
INGREDIENTS AND APPEARANCE
PANAMA JACK BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:13630-0137 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 24.93 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 62.325 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 41.55 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 41.55 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ISOBORNYL ACRYLATE (UNII: IX0PRH184P) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) DIBUTYL MALEATE (UNII: 4X371TMK9K) VINYL ACETATE (UNII: L9MK238N77) Product Characteristics Color yellow Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13630-0137-4 177 mL in 1 CAN; Type 0: Not a Combination Product 01/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/30/2019 Labeler - Prime Packaging, Inc. (805987059) Registrant - Prime Packaging, Inc. (805987059) Establishment Name Address ID/FEI Business Operations Prime Enterprises, Inc. 101946028 manufacture(13630-0137) , analysis(13630-0137) Establishment Name Address ID/FEI Business Operations Prime Packaging, Inc. 805987059 label(13630-0137) , pack(13630-0137)
